The partnership intends to develop the FoundationOne CDx and FoundationOne Liquid CDx genomic tests as companion diagnostics for treatment of patients with non-small cell lung cancer
Foundation Medicine and Pierre Fabre Laboratories to develop companion diagnostics for NSCLC treatment. (Credit: Testalize.me on Unsplash)
US-based Foundation Medicine and Pierre Fabre Laboratories have agreed to partner on developing companion diagnostics for new targeted therapies for the treatment of patients with non-small cell lung cancer (NSCLC).
The partnership intends to develop the FoundationOne CDx and FoundationOne Liquid CDx genomic tests as companion diagnostics for NSCLC treatment.
Together, the companies will apply for regulatory approval for Foundation Medicine’s assays that detect mutations, such as BRAFV600E.
Patients will be identified for potential treatment in the European Union using Pierre Fabre’s BRAF/MEK inhibitor combination regimen, which includes BRAFTOVI (encorafenib) and MEKTOVI (binimetinib).
This combination therapy was assessed in a clinical trial supported by France-based Pierre Fabre and sponsored by Pfizer.
It is currently being examined by the European Medicines Agency for patients with advanced NSCLC that has a BRAFV600 mutation.
Pierre Fabre medical and patient consumer department head Núria Perez-Cullell said: “Today, as the number of indications and approvals in oncology grow rapidly, companion diagnostics provide information that is critical for the safe and effective use of targeted therapies. And that’s why we are excited to work with Foundation Medicine.
“Thanks to those companion diagnostics, physicians will have comprehensive, reliable information about what is driving a patient’s cancer, such as BRAFV600E mutations, so they can make personalised treatment decisions.”
The US Food and Drug Administration (FDA) has approved FoundationOne CDx and FoundationOne Liquid CDx as in-vitro diagnostic tools for the detection of potentially targetable mutations in solid tumour samples derived from blood and tissue.
Foundation Medicine is said to have the only FDA-approved portfolio of complete genomic profiling tests.
The range offers doctors both blood- and tissue-based testing options to identify genomic alterations such as BRAFV600E to help guide individualised therapy decisions.
The company has shown initial success in navigating the new In Vitro Diagnostics Regulation (IVDR) in Europe via several global trials or using patient samples from European Union member states.
Foundation Medicine chief biopharma business officer Troy Schurr said: “High-quality companion diagnostics play a crucial role in helping physicians match their patients with targeted treatment options.
“We are excited to support Pierre Fabre Laboratories in offering more treatment options for cancer patients, and to increase access to precision therapies in the European Union.”